First US Cases for MIS Nasal Valve Collapse Device

Nasal Obstruction specialist company Spirox™, Inc., has announced the FDA Clearance and first US cases with the LATERA™ Absorbable Nasal Implant. LATERA provides ENTs and facial plastic surgeons with a new minimally invasive option to support the upper and lower lateral nasal cartilages.

Background

Here’s a new subject for our medtech community: The majority of patients undergoing nasal obstruction procedures suffer from what is loosely termed weak lateral cartilage, which can result in nasal valve collapse. Menlo Park-based Spirox commits itself to transforming the treatment of nasal obstruction, having identified the condition as frequently undiagnosed and as such, an unmet need.

Spirox’s recently FDA cleared LATERA is an absorbable polymer implant, indicated for supporting the upper and lower lateral nasal cartilage. The company claims its minimally invasive technology is intuitive and can be delivered by ENTs or facial plastic surgeons.

Prior to the newly reported US cases, a multi-center clinical study conducted in Germany showed that patients that received a LATERA implant alone experienced a reduction in nasal obstruction symptoms at one year, with results in the range of more invasive techniques and without a cosmetic downside.

Latera remains available only in the USA.

Physician comments

“Nasal obstruction takes a significant toll on patient quality of life, but is often undertreated and underdiagnosed. If we don’t look for nasal valve collapse in these patients, we’re not addressing the entire problem. By providing an intuitive and effective way to support nasal lateral cartilage, LATERA has the potential to improve breathing for our patients,” said Dean Toriumi, MD, professor of Otolaryngology-Head and Neck Surgery at the University of Illinois at Chicago, and past president of the American Academy of Facial Plastic and Reconstructive Surgeons (AAFPRS).

Pablo Stolovitzky, MD, clinical assistant professor at Emory University and past chairman of the Board of Governors of the American Academy of Otolaryngology-Head & Neck Surgery (AAO-HNS), was among the first physicians to perform a LATERA case in the US. He noted, “LATERA is an important development for nasal obstruction patients when a standard procedure treating the septum and turbinates is often not enough. LATERA provides us with a minimally-invasive solution to support nasal lateral cartilage. I was able to place the implant on my first attempt, and I expect that the physician learning curve will be short.”

Company comments

“We have worked with physician leaders to find a solution to a major clinical need. The research and development behind the innovation is complex, but the technique is elegant and intuitive,” said Duke Rohlen, Spirox chief executive officer. “LATERA gives physicians a new option to support lateral cartilage, enabling a more complete means for addressing their patients’ nasal obstruction symptoms.”